510(k) · Cleared
ClearedINNOVANCE Antithrombin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostic Products GmbH · JBQ Antithrombin Iii Quantitation
Cleared on Mar 28, 2025 as substantially equivalent to K933125 (Behring Diagnostics, Inc., 1994) after a 184-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 28, 2025
- Review
- 184 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933125 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933125 Berichrom Antithrombin Iii (a)Behring Diagnostics, Inc. · 1994
- This deviceK242952 INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933125 | Berichrom Antithrombin Iii (a) | Behring Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JBQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K933125 | Berichrom Antithrombin Iii (a)Summary page 5…Regulatory Class: Class II 510(k) Review Panel Hematology 3. Predicate Device Name of Device / 510(k): Berichrom® Antithrombin III (A) / K933125 Regulation Number: 21CFR 864.7060 Regulation Description: Antithrombin III assay Product Code: JPE… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K933125.
How does its category compare?
All JBQ devicesJBQ Antithrombin Iii Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JBQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JBQ
Too few JBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JBQ
No recall names JBQ since 2007.
Adverse event reports per year · JBQ
1in 2023
MAUDE reports naming product code JBQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
INNOVANCE Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
INNOVANCE Antithrombin is indicated as an aid in monitoring antithrombin activity to support QFITLIA (fitusiran) dosing in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242952: INNOVANCE Antithrombin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242952
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026